EN ISO 11073-10101:2005/A1:2017

SLOVENSKI STANDARD
01-februar-2018
Zdravstvena informatika – Komunikacija medicinskih naprav na mestu oskrbe –
10101. del: Nomenklatura (ISO/IEEE 11073-10101:2004/Amd 1:2017)
Health informatics - Point-of-care medical device communication - Part 10101:
Nomenclature - Amendment 1: Additional definitions (ISO/IEEE 11073-10101:2004/Amd
1:2017)
Medizinische Informatik - Kommunikation patientennaher medizinischer Geräte - Teil
10101: Nomenklatur - Änderung (ISO/IEEE 11073-10101:2004/Amd 1:2017)
Informatique de santé - Communication entre dispositifs médicaux sur le site des soins -
Partie 10101: Nomenclature - Amendement 1 (ISO/IEEE 11073-10101:2004/Amd
1:2017)
Ta slovenski standard je istoveten z: EN ISO 11073-10101:2005/A1:2017
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 11073-
EUROPEAN STANDARD
10101:2005/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2017
ICS 01.040.35; 35.240.80
English Version
Health informatics - Point-of-care medical device
communication - Part 10101: Nomenclature - Amendment
1: Additional definitions (ISO/IEEE 11073-
10101:2004/Amd 1:2017)
Informatique de santé - Communication entre Medizinische Informatik - Kommunikation
dispositifs médicaux sur le site des soins - Partie patientennaher medizinischer Geräte - Teil 10101:
10101: Nomenclature - Amendement 1 (ISO/IEEE Nomenklatur - Änderung 1 (ISO/IEEE 11073-
11073-10101:2004/Amd 1:2017) 10101:2004/Amd 1:2017)
This amendment A1 modifies the European Standard EN ISO 11073-10101:2005; it was approved by CEN on 13 April 2017.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-10101:2005/A1:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
European foreword
This document (EN ISO 11073-10101:2005/A1:2017) has been prepared by Technical Committee
ISO/TC 215 “Health informatics” in collaboration with Technical Committee CEN/TC 251 “Health
informatics” the secretariat of which is held by NEN.
This Amendment to the European Standard EN ISO 11073-10101:2005 shall be given the status of a
national standard, either by publication of an identical text or by endorsement, at the latest by May
2018, and conflicting national standards shall be withdrawn at the latest by May 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO/IEEE 11073-10101:2004/Amd1:2017 has been approved by CEN as EN ISO 11073-
10101:2005/A1:2017 without any modification.

INTERNATIONAL ISO/IEEE
STANDARD 11073-10101
First edition
2004‐12‐15
AMENDMENT 1
2017‐10
Health informatics — Point-of-care medical
device communication —
Part 10101:
Nomenclature
AMENDMENT 1: Additional definitions
Informatique de santé — Communication entre dispositifs médicaux sur le
site des soins —
Partie 10101: Nomenclature
AMENDEMENT 1: Définitions supplementaires
Reference number
ISO/IEEE 11073‐10101:2004/Amd 1:2017(E)
©
IEEE 2015
ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
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ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
Foreword
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Amendment 1 to ISO/IEEE 11073‐10101:2004/Amd 1:2017 was prepared by the 11073 Committee of the
Engineering in Medicine and Biology Society of the IEEE (as IEEE 11073‐10101:2004). It was adopted by
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© IEEE 2015 – All rights reserved iii

IEEE Std 11073-10101a™-2015
(Amendment to
ISO/IEEE 11073-10101:2004)
Health informatics—Point-of-care medical device communication
Part 10101: Nomenclature
Amendment 1: Additional Definitions
Sponsor
IEEE 11073™ Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 5 December 2015
IEEE-SA Standards Board
ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for point-of-care (POC)
medical device communication (MDC), the nomenclature defined by the base ISO/IEEE 11073-
10101:2004 nomenclature standard is extended by this amendment. Significant extensions to
support haemodynamics, respiration, ventilation and anesthesia monitoring, blood gas, urine,
fluid-related metrics, and neurology, as well as units of measurements and measurement sites,
are included. Formal definitions for observation identifiers used by the IEEE 11073 Personal
Health Device standards and additional attributes for reporting their regulatory and certification
status are also captured and provided. Information attributes to support alert communication and
accurate medical device time synchronization and timekeeping are also defined.
Keywords: alert communication, anesthesia, blood gas, codes, Continua, fluid-related metrics,
haemodynamics, IEEE 11073-10101a, IHE PCD, information model, ISO/IEEE 11073-10101,
measurement sites, medical device certification, medical device communication, neurology,
nomenclature, NTP, ontology, patient, PCHA, Personal Connected Health Alliance, POC, point-
of-care, respiration, semantics, service model, terminology, time synchronization, timekeeping,
units of measure, urine, ventilation
xx
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vi
ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
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